(28 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML algorithms (like training/test sets, AUC, sensitivity/specificity of an algorithm). The device description focuses on the hardware components and the use of OCT and fluoroscopy for orientation.
No
Explanation: The device is intended to facilitate the placement of guidewires for diagnostic or interventional procedures, but it does not directly treat a disease or condition. It is a tool used in preparation for other percutaneous interventions.
No
Explanation: The device is intended to facilitate guidewire placement using OCT-assisted orientation as an adjunct to fluoroscopy, not to diagnose a condition. While it uses OCT for orientation, its primary function is procedural guidance for intraluminal placement, not diagnosis.
No
The device description explicitly states that the system consists of a catheter, a console, and an umbilical, which are all hardware components.
Based on the provided information, the Ocelot PIXL System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used to facilitate the intraluminal placement of guidewires within the peripheral vasculature. This is a procedure performed in vivo (within the living body).
- Device Description: The device components (catheter, console, umbilical) and their function (OCT-assisted orientation during a procedure) are consistent with a medical device used for intervention within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Ocelot PIXL System does not perform this function.
The Ocelot PIXL System is a medical device used for a therapeutic and interventional procedure within the patient's body.
N/A
Intended Use / Indications for Use
The Ocelot PIXL System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot PIXL System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY, PDU
Device Description
The Ocelot PIXL System consists of the Ocelot PIXL Catheter, the Lightbox Console and the Umbilical. The Ocelot PIXL Catheter is an over-the-wire device that is compatible with a 5F sheath and 0.014" guidewire. The Ocelot PIXL Catheter is available in two different lengths; 135cm working length or 150cm working length and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), fluoroscopy
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Visual and Dimensional Verification
- Tensile Testing
- Torque Testing
- Guidewire advancement
- Device Advancement
- Tip Deflection Testing
- Device leak testing
- Luer Leak Testing
- Spiral Blade Functional Testing
- Coating Friction Testing
- Tip Penetration Testing
- In Vitro Simulated Use Testing
- Shelf Life Testing
- Tip-Stall Testing
- Tip Penetration Testing
- Flexibility/Trackability
Key results: The above testing confirmed that the Ocelot PIXL Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications and external standard requirements. Results of non-clinical testing demonstrated that the Ocelot PIXL Catheter is substantially equivalent to the predicate device for the stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Avinger, Inc.
.
510(k) Summary
DEC 1 4 2012
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- A. Name and Address of Applicant Avinger, Inc. 400 Chesapeake Drive Redwood City, CA 94063 B. Contact Person Babu Periasamy Manager, Regulatory Affairs and Compliance (650) 241-7006 C. Date Prepared November 15, 2012 D. Device Name
- Trade Name: Ocelot PIXL Catheter
| Common Name: . | Percutaneous Catheter |
|---|---|
| Classification Name: | Percutaneous Catheter |
E. Device Classification
| Classification: | 21 CFR §870.1250 |
|---|---|
| Product Code: | DQY |
| Device Class: | Class II |
F. Predicate Device
The Ocelot PIXL Catheter is substantially equivalent to the original Ocelot Catheter (K122380).
G. Device Description
The Ocelot PIXL System consists of the Ocelot PIXL Catheter, the Lightbox Console and the Umbilical. The Ocelot PIXL Catheter is an over-the-wire device that is compatible with a 5F sheath and 0.014" guidewire. The Ocelot PIXL Catheter is available in two different lengths; 135cm working length or 150cm working length and incorporates an optical fiber used to facilitate Optical Coherence Tomography (OCT)-assisted orientation as an adjunct to fluoroscopy.
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H. Intended Use
The Ocelot PIXL System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation as an adjunct to fluoroscopy. The Ocelot PIXL System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
I, Substantial Equivalence
The Ocelot PIXL Catheter is substantially equivalent to the originally cleared Ocelot Catheter (K122380). The subject and predicate devices have the same mechanism of action (manual advancement) and perform the same function (placement of guidewires beyond stenotic lesions in the peripheral vasculature). The Ocelot PIXL Catheter is a smaller (5F vs. 6F); longer version (150/135cm vs. 110cm) of the Ocelot Catheter. The Ocelot PIXL Catheter's smaller diameter (5F) and working lengths are similar to the Avinger Kittycat and Kittycat 2 Catheters (K120273). The other design changes implemented to create Ocelot PIXL Catheter include a slightly smaller drive shaft and torque shaft, a longer hypotube in the handle assembly, a strain relief just distal to the rotator knob and the addition of a coil around the shaped distal segment. The changes to the Ocelot Catheter cleared under K122338 results in no significant changes to technological characteristics and do not raise any new issues of safety or effectiveness.
J. Non-Clinical Performance Data
The following non-clinical testing was previously conducted with the Ocelot PIXL Catheter to support a determination of substantial equivalence to the predicate device.
| • Visual and Dimensional Verification | • Spiral Blade Functional Testing |
|---|---|
| • Tensile Testing | • Coating Friction Testing |
| • Torque Testing | • Tip Penetration Testing |
| • Guidewire advancement | • In Vitro Simulated Use Testing |
| • Device Advancement | • Shelf Life Testing |
| • Tip Deflection Testing | • Tip-Stall Testing |
| • Device leak testing | • Tip Penetration Testing |
| • Luer Leak Testing | • Flexibility/Trackability |
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The above testing confirmed that the Ocelot PIXL Catheter performs according to the stated intended use. All data fell well within pre-determined product specifications and external standard requirements. Results of non-clinical testing demonstrated that the Ocelot PIXL Catheter is substantially equivalent to the predicate device for the stated intended use.
K. Conclusions
The Ocelot PIXL Catheter has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. Non-clinical testing was conducted to validate the performance of the devices and ensure the Ocelot. PIXL Catheter functions as intended and meet design specifications. The comparison and non-clinical results demonstrate that the devices are substantially equivalent to the predicate device for the stated intended use.
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Avinger, Inc. Mr. Babu Periasamy Manager, Regulatory and Quality Affairs 400 Chesapeake Drive Redwood City, CA 94063
SEP 1 8 2013
Re: K123532
Trade/Device Name: Ocelot PIXL Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: November 15, 2012 Received: November 16, 2012
Dear Mr. Periasamy:
This letter corrects our substantially equivalent letter of December 14, 2012.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Zm.Z
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Avinger, Inc.
Indications for Use Statement
510(k) Number (if known): K_________________________________________________________________________________________________________________________________________________
Ocelot PIXL Catheter Device Name:
Indications for Use:
The Ocelot PIXL System is intended to facilitate the intraluminal placement of conventional I the occlor I ha oystem is including sub and chronic total occlusions) in the guidewires beyond stenotic to further percutaneous intervention using OCT-assisted perientation as an adjunct to fluoroscopy. The Ocelot PIXL System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.
| Prescription Use | X |
|---|---|
| ------------------ | --- |
Or
| Over-The-Counter Use | _________________ |
|---|---|
| ---------------------- | ------------------- |
(per 21 CFR 801.109)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K123532 |
Appendix E, Page 2 of 2